Flexible circuit electrode array with at least one tack opening

ABSTRACT

The present invention provides a flexible circuit electrode array adapted for neural stimulation, comprising: a polymer base layer; metal traces deposited on said polymer base layer, including electrodes suitable to stimulate neural tissue; a polymer top layer deposited on said polymer base layer and said metal traces at least one tack opening; wherein said polymer base layer, said metal traces and said polymer top layer are thermoformed in a three dimensional shape. 
     The present invention provides further a method of making a flexible circuit electrode array comprising depositing a polymer base layer; depositing metal on said polymer base layer; patterning said metal to form metal traces; depositing a polymer top layer on said polymer base layer and said metal traces; preparing at least one tack opening; and heating said flexible circuit electrode array in a mold to form a three dimensional shape in said flexible circuit electrode array.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.60/815,311, “Flexible Circuit Electrode Array with at least one TackOpening”, filed Jun. 21, 2006, the disclosure of which is incorporatedherein by reference.

This application is a Continuation-In-Part of U.S. application Ser. No.11/413,689, “Flexible Circuit Electrode Array”, filed Apr. 28, 2006,which is a Continuation-In-Part of U.S. application Ser. No. 11/207,644,filed Aug. 19, 2005 which claims the benefit of U.S. ProvisionalApplication No. 60/676,008, “Thin Film Electrode Array”, filed Apr. 28,2005, the disclosures of all are incorporated herein by reference.

GOVERNMENT RIGHTS NOTICE

This invention was made with government support under grant No.R24EY12893-01, awarded by the National Institutes of Health. Thegovernment has certain rights in the invention.

FIELD OF THE INVENTION

The present invention is generally directed to neural stimulation andmore specifically to an improved electrode array for neural stimulation.

BACKGROUND OF THE INVENTION

In 1755 LeRoy passed the discharge of a Leyden jar through the orbit ofa man who was blind from cataract and the patient saw “flames passingrapidly downwards.” Ever since, there has been a fascination withelectrically elicited visual perception. The general concept ofelectrical stimulation of retinal cells to produce these flashes oflight or phosphenes has been known for quite some time. Based on thesegeneral principles, some early attempts at devising prostheses foraiding the visually impaired have included attaching electrodes to thehead or eyelids of patients. While some of these early attempts met withsome limited success, these early prosthetic devices were large, bulkyand could not produce adequate simulated vision to truly aid thevisually impaired.

In the early 1930's, Foerster investigated the effect of electricallystimulating the exposed occipital pole of one cerebral hemisphere. Hefound that, when a point at the extreme occipital pole was stimulated,the patient perceived a small spot of light directly in front andmotionless (a phosphene). Subsequently, Brindley and Lewin (1968)thoroughly studied electrical stimulation of the human occipital(visual) cortex. By varying the stimulation parameters, theseinvestigators described in detail the location of the phosphenesproduced relative to the specific region of the occipital cortexstimulated. These experiments demonstrated: (1) the consistent shape andposition of phosphenes; (2) that increased stimulation pulse durationmade phosphenes brighter; and (3) that there was no detectableinteraction between neighboring electrodes which were as close as 2.4 mmapart.

As intraocular surgical techniques have advanced, it has become possibleto apply stimulation on small groups and even on individual retinalcells to generate focused phosphenes through devices implanted withinthe eye itself. This has sparked renewed interest in developing methodsand apparati to aid the visually impaired. Specifically, great efforthas been expended in the area of intraocular retinal prosthesis devicesin an effort to restore vision in cases where blindness is caused byphotoreceptor degenerative retinal diseases; such as retinitispigmentosa and age related macular degeneration which affect millions ofpeople worldwide.

Neural tissue can be artificially stimulated and activated by prostheticdevices that pass pulses of electrical current through electrodes onsuch a device. The passage of current causes changes in electricalpotentials across visual neuronal membranes, which can initiate visualneuron action potentials, which are the means of information transfer inthe nervous system.

Based on this mechanism, it is possible to input information into thenervous system by coding the sensory information as a sequence ofelectrical pulses which are relayed to the nervous system via theprosthetic device. In this way, it is possible to provide artificialsensations including vision.

One typical application of neural tissue stimulation is in therehabilitation of the blind. Some forms of blindness involve selectiveloss of the light sensitive transducers of the retina. Other retinalneurons remain viable, however, and may be activated in the mannerdescribed above by placement of a prosthetic electrode device on theinner (toward the vitreous) retinal surface (epiretinal). This placementmust be mechanically stable, minimize the distance between the deviceelectrodes and the visual neurons, control the electronic fielddistribution and avoid undue compression of the visual neurons.

In 1986, Bullara (U.S. Pat. No. 4,573,481) patented an electrodeassembly for surgical implantation on a nerve. The matrix was siliconewith embedded iridium electrodes. The assembly fit around a nerve tostimulate it.

Dawson and Radtke stimulated cat's retina by direct electricalstimulation of the retinal ganglion cell layer. These experimentersplaced nine and then fourteen electrodes upon the inner retinal layer(i.e., primarily the ganglion cell layer) of two cats. Their experimentssuggested that electrical stimulation of the retina with 30 to 100 μAcurrent resulted in visual cortical responses. These experiments werecarried out with needle-shaped electrodes that penetrated the surface ofthe retina (see also U.S. Pat. No. 4,628,933 to Michelson).

The Michelson '933 apparatus includes an array of photosensitive deviceson its surface that are connected to a plurality of electrodespositioned on the opposite surface of the device to stimulate theretina. These electrodes are disposed to form an array similar to a “bedof nails” having conductors which impinge directly on the retina tostimulate the retinal cells. U.S. Pat. No. 4,837,049 to Byers describesspike electrodes for neural stimulation. Each spike electrode piercesneural tissue for better electrical contact. U.S. Pat. No. 5,215,088 toNorman describes an array of spike electrodes for cortical stimulation.Each spike pierces cortical tissue for better electrical contact.

The art of implanting an intraocular prosthetic device to electricallystimulate the retina was advanced with the introduction of retinal tacksin retinal surgery. De Juan, et al. at Duke University Eye Centerinserted retinal tacks into retinas in an effort to reattach retinasthat had detached from the underlying choroid, which is the source ofblood supply for the outer retina and thus the photoreceptors. See,e.g., E. de Juan, et al., 99 Am. J. Ophthalmol. 272 (1985). Theseretinal tacks have proved to be biocompatible and remain embedded in theretina, and choroid/sclera, effectively pinning the retina against thechoroid and the posterior aspects of the globe. Retinal tacks are oneway to attach a retinal electrode array to the retina. U.S. Pat. No.5,109,844 to de Juan describes a flat electrode array placed against theretina for visual stimulation. U.S. Pat. No. 5,935,155 to Humayundescribes a retinal prosthesis for use with the flat retinal arraydescribed in de Juan.

SUMMARY OF THE INVENTION

Polymer materials are useful as electrode array bodies for neuralstimulation. They are particularly useful for retinal stimulation tocreate artificial vision, cochlear stimulation to create artificialhearing, or cortical stimulation for many purposes. Regardless of whichpolymer is used, the basic construction method is the same. A layer ofpolymer is laid down, commonly by some form of chemical vapordeposition, spinning, meniscus coating or casting. A layer of metal,preferably platinum, is applied to the polymer and patterned to createelectrodes and leads for those electrodes. Patterning is commonly doneby photolithographic methods. A second layer of polymer is applied overthe metal layer and patterned to leave openings for the electrodes, oropenings are created later by means such as laser ablation. Hence thearray and its supply cable are formed of a single body. Alternatively,multiple alternating layers of metal and polymer may be applied toobtain more metal traces within a given width.

The pressure applied against the retina, or other neural tissue, by anelectrode array is critical. Too little pressure causes increasedelectrical resistance between the array and retina, along with electricfield dispersion. Too much pressure may block blood flow causing retinalischemia and hemorrhage. Pressure on the neural retina may also blockaxonal flow or cause neuronal atrophy leading to optic atrophy. Commonflexible circuit fabrication techniques such as photolithographygenerally require that a flexible circuit electrode array be made flat.Since the retina is spherical, a flat array will necessarily apply morepressure near its edges, than at its center. Further, the edges of aflexible circuit polymer array may be quite sharp and cut the delicateretinal tissue. With most polymers, it is possible to curve them whenheated in a mold. By applying the right amount of heat to a completedarray, a curve can be induced that matches the curve of the retina. Witha thermoplastic polymer such as liquid crystal polymer, it may befurther advantageous to repeatedly heat the flexible circuit in multiplemolds, each with a decreasing radius. Further, it is advantageous to addmaterial along the edges of a flexible circuit array. Particularly, itis advantageous to add material that is more compliant than the polymerused for the flexible circuit array.

It is further advantageous to provide a fold or twist in the flexiblecircuit array at the point where it passes through the sclera.Additional material may be added inside and outside the fold to promotea good seal with the scleral tissue.

The novel features of the invention are set forth with particularity inthe appended claims. The invention will be best understood from thefollowing description when read in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the implanted portion of the preferredretinal prosthesis.

FIG. 2 is a side view of the implanted portion of the preferred retinalprosthesis showing the fan tail in more detail.

FIG. 3A-3E depict molds for forming the flexible circuit array in acurve.

FIG. 4 depicts an alternate view of the invention with ribs to helpmaintain curvature and prevent retinal damage.

FIG. 5 depicts an alternative view of the invention with ribs to helpmaintain curvature and prevent retinal damage fold of the flexiblecircuit cable and a fold A between the circuit electrode array and theflexible circuit cable.

FIG. 6 depicts the flexible circuit array before it is folded andattached to the implanted portion.

FIG. 7 depicts the flexible circuit array folded.

FIG. 8 depicts a flexible circuit array with a protective skirt.

FIG. 9 depicts a flexible circuit array with a protective skirt bondedto the back side of the flexible circuit array.

FIG. 10 depicts a flexible circuit array with a protective skirt bondedto the front side of the flexible circuit array.

FIG. 11 depicts a flexible circuit array with a protective skirt bondedto the back side of the flexible circuit array and molded around theedges of the flexible circuit array.

FIG. 12 depicts a flexible circuit array with a protective skirt bondedto the back side of the flexible circuit array and molded around theedges of the flexible circuit array and flush with the front side of thearray.

FIG. 13 is an enlarged view of a single electrode within the flexiblecircuit electrode array.

FIG. 14 shows a top view of a flexible electrode with a tack opening.

FIG. 15 shows a top view of a modified tack opening, which is madethinner and has an increased open angle.

FIG. 16 shows a cross-sectional view of a modified tack opening, whichis made thinner and has an increased open angle.

FIG. 17 shows a top view of a modified tack opening, which can be thinheight, rotate better, adjust the angle better and use softer material.

FIG. 18 shows a cross-sectional view of a modified tack opening, whichcan be thin height, rotate better, adjust the angle better and usesofter material.

FIG. 19 shows a top view of a modified tack opening, which can adjustthe diameter, and adjust thickness, can use softer materials, can bemanufactured integrally or discretely, flush or protruding.

FIG. 20 shows a cross-sectional view of a modified tack opening, whichcan adjust the diameter, and adjust thickness, can use softer materials,can be manufactured integrally or discretely, flush or protruding.

FIG. 21 shows a cross-sectional view of a modified tack opening, whichapplies to the modifications in FIGS. 15-20, which can be flat (disk) orcurved (hemispherical), and can be fabricated with part or addedseparately. The potential benefit lies in lifting global electroderegion off retina by a small amount and localizing high pressure ontissue to tack site.

FIG. 22 shows a top view of a flexible electrode with a tack openingcontaining membrane material.

FIG. 23 shows a cross-sectional view of a flexible electrode with a tackopening containing membrane material.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description is of the best mode presently contemplated forcarrying out the invention. This description is not to be taken in alimiting sense, but is made merely for the purpose of describing thegeneral principles of the invention. The scope of the invention shouldbe determined with reference to the claims.

FIG. 1 shows a perspective view of the implanted portion of thepreferred retinal prosthesis. A flexible circuit 1 includes a flexiblecircuit electrode array 10 which is mounted by a retinal tack (notshown) or similar means to the epiretinal surface. The flexible circuitelectrode array 10 is electrically coupled by a flexible circuit cable12, which pierces the sclera and is electrically coupled to anelectronics package 14, external to the sclera.

The electronics package 14 is electrically coupled to a secondaryinductive coil 16. Preferably the secondary inductive coil 16 is madefrom wound wire. Alternatively, the secondary inductive coil 16 may bemade from a flexible circuit polymer sandwich with wire traces depositedbetween layers of flexible circuit polymer. The electronics package 14and secondary inductive coil 16 are held together by a molded body 18.The molded body 18 may also include suture tabs 20. The molded body 18narrows to form a strap 22 which surrounds the sclera and holds themolded body 18, secondary inductive coil 16, and electronics package 14in place. The molded body 18, suture tabs 20 and strap 22 are preferablyan integrated unit made of silicone elastomer. Silicone elastomer can beformed in a pre-curved shape to match the curvature of a typical sclera.However, silicone remains flexible enough to accommodate implantationand to adapt to variations in the curvature of an individual sclera. Thesecondary inductive coil 16 and molded body 18 are preferably ovalshaped. A strap 22 can better support an oval shaped coil.

It should be noted that the entire implant is attached to and supportedby the sclera. An eye moves constantly. The eye moves to scan a sceneand also has a jitter motion to improve acuity. Even though such motionis useless in the blind, it often continues long after a person has losttheir sight. By placing the device under the rectus muscles with theelectronics package in an area of fatty tissue between the rectusmuscles, eye motion does not cause any flexing which might fatigue, andeventually damage, the device.

FIG. 2 shows a side view of the implanted portion of the retinalprosthesis, in particular, emphasizing the fan tail 24. When implantingthe retinal prosthesis, it is necessary to pass the strap 22 under theeye muscles to surround the sclera. The secondary inductive coil 16 andmolded body 18 must also follow the strap 22 under the lateral rectusmuscle on the side of the sclera. The implanted portion of the retinalprosthesis is very delicate. It is easy to tear the molded body 18 orbreak wires in the secondary inductive coil 16. In order to allow themolded body 18 to slide smoothly under the lateral rectus muscle, themolded body 18 is shaped in the form of a fan tail 24 on the endopposite the electronics package 14.

The flexible circuit 1 is a made by the following process. First, alayer of polymer (such as polyimide, fluoro-polymers, silicone or otherpolymers) is applied to a support substrate (not part of the array) suchas glass. Layers may be applied by spinning, meniscus coating, casting,sputtering or other physical or chemical vapor deposition, or similarprocess. Subsequently, a metal layer is applied to the polymer. Themetal is patterned by photolithographic process. Preferably, aphoto-resist is applied and patterned by photolithography followed by awet etch of the unprotected metal. Alternatively, the metal can bepatterned by lift-off technique, laser ablation or direct writetechniques.

It is advantageous to make this metal thicker at the electrode and bondpad to improve electrical continuity. This can be accomplished throughany of the above methods or electroplating. Then, the top layer ofpolymer is applied over the metal. Openings in the top layer forelectrical contact to the electronics package 14 and the electrodes maybe accomplished by laser ablation or reactive ion etching (RIE) orphotolithograph and wet etch. Making the electrode openings in the toplayer smaller than the electrodes promotes adhesion by avoidingdelaminating around the electrode edges.

The pressure applied against the retina by the flexible circuitelectrode array is critical. Too little pressure causes increasedelectrical resistance between the array and retina. It should be notedthat while the present invention is described in terms of application tothe retina, the techniques described are equally applicable to manyforms of neural stimulation. Application to the retina requires a convexspherical curve. Application to the cochlea requires a constant curve inone dimension and a spiral curve in the other. Application to thecerebral cortex requires a concave spherical curve. Cortical stimulationis useful for artificial vision or hearing, touch and motor control forlimb prostheses, deep brain stimulation for Parkinson's disease andmultiple sclerosis, and many other applications.

Common flexible circuit fabrication techniques such as photolithographygenerally require that a flexible circuit electrode array be made flat.Since the retina is spherical, a flat array will necessarily apply morepressure near its edges, than at its center. With most polymers, it ispossible to curve them when heated in a mold. By applying the rightamount of heat to a completed array, a curve can be induced that matchesthe curve of the retina. To minimize warping, it is often advantageousto repeatedly heat the flexible circuit in multiple molds, each with adecreasing radius. FIG. 3 illustrates a series of molds according to thepreferred embodiment. Since the flexible circuit will maintain aconstant length, the curvature must be slowly increased along thatlength. As the curvature 30 decreases in successive molds (FIGS. 3A-3E)the straight line length between ends 32 and 34, must decrease to keepthe length along the curvature 30 constant, where mold 3E approximatesthe curvature of the retina or other desired neural tissue. The moldsprovide a further opening 36 for the flexible circuit cable 12 of thearray to exit the mold without excessive curvature.

It should be noted that suitable polymers include thermoplasticmaterials and thermoset materials. While a thermoplastic material willprovide some stretch when heated a thermoset material will not. Thesuccessive molds are, therefore, advantageous only with a thermoplasticmaterial. A thermoset material works as well in a single mold as it willwith successive smaller molds. It should be noted that, particularlywith a thermoset material, excessive curvature in three dimensions willcause the polymer material to wrinkle at the edges. This can causedamage to both the array and the retina. Hence, the amount of curvatureis a compromise between the desired curvature, array surface area, andthe properties of the material.

Referring to FIG. 4, the edges of the polymer layers are often sharp.There is a risk that the sharp edges of a flexible circuit will cut intodelicate retinal tissue. It is advantageous to add a soft material, suchas silicone, to the edges of a flexible circuit electrode array to roundthe edges and protect the retina. Silicone around the entire edge maymake the flexible circuit less flexible. So, it is advantageous toprovide silicone bumpers or ribs to hold the edge of the flexiblecircuit electrode array away from the retinal tissue. Curvature 40 fitsagainst the retina. The leading edge 44 is most likely to cause damageand is therefore fit with molded silicone bumper. Also, edge 46, wherethe array lifts off the retina can cause damage and should be fit with abumper. Any space along the side edges of curvature 40 may cause damageand may be fit with bumpers as well. It is also possible for theflexible circuit cable 12 of the electrode array to contact the retina.It is, therefore, advantageous to add periodic bumpers along theflexible circuit cable 12.

It is also advantageous to create a reverse curve or service loop in theflexible circuit cable 12 of the flexible circuit electrode array togently lift the flexible circuit cable 12 off the retina and curve itaway from the retina, before it pierces the sclera at a sclerotomy. Itis not necessary to heat curve the service loop as described above, theflexible circuit electrode array can simply be bent or creased uponimplantation. This service loop reduces the likelihood of any stressexerted extraocularly from being transmitted to the electrode region andretina. It also provides for accommodation of a range of eye sizes.

With existing technology, it is necessary to place the implanted controlelectronics outside of the sclera, while a retinal flexible circuitelectrode array must be inside the sclera in order to contact theretina. The sclera is cut through at the pars plana, forming asclerotomy, and the flexible circuit passed through the sclerotomy. Aflexible circuit is thin but wide. The more electrode wires, the widerthe flexible circuit must be. It may be difficult to seal a sclerotomyover a flexible circuit wide enough to support enough wires for a highresolution array. A narrow sclerotomy is preferable.

FIG. 5 depicts a further embodiment of the part of the prosthesis shownin FIG. 4 with a fold A between the circuit electrode array 10 and theflexible circuit cable 12. The angle in the fold A also called ankle hasan angle of 1°-180°, preferably 80°-120°. The fold A is advantageoussince it reduces tension and enables an effective attachment of theflexible electrode circuit array 10 to the retina.

FIG. 6 shows the flexible circuit electrode array prior to folding andattaching the array to the electronics package 14. At one end of theflexible circuit cable 12 is an interconnection pad 52 for connection tothe electronics package 14. At the other end of the flexible circuitcable 12 is the flexible circuit electrode array 10. Further, anattachment point 54 is provided near the flexible circuit electrodearray 10. A retina tack (not shown) is placed through the attachmentpoint 54 to hold the flexible circuit electrode array 10 to the retina.A stress relief 55 is provided surrounding the attachment point 54. Thestress relief 55 may be made of a softer polymer than the flexiblecircuit, or it may include cutouts or thinning of the polymer to reducethe stress transmitted from the retina tack to the flexible circuitelectrode array 10. The flexible circuit cable 12 is formed in a dog legpattern so than when it is folded at fold 48 it effectively forms astraight flexible circuit cable 12 with a narrower portion at the fold48 for passing through the sclerotomy.

FIG. 7 shows the flexible circuit electrode array after the flexiblecircuit cable 12 is folded at the fold 48 to form a narrowed section.The flexible circuit cable 12 may include a twist or tube shape as well.With a retinal prosthesis as shown in FIG. 1, the bond pad 52 forconnection to the electronics package 14 and the flexible circuitelectrode array 10 are on opposite side of the flexible circuit. Thisrequires patterning, in some manner, both the base polymer layer and thetop polymer layer. By folding the flexible circuit cable 12 of theflexible circuit electrode array 10, the openings for the bond pad 52and the electrodes are on the top polymer layer and only the top polymerlayer needs to be patterned.

Also, since the narrowed portion of the flexible circuit cable 12pierces the sclera, shoulders formed by opposite ends of the narrowedportion help prevent the flexible circuit cable 12 from moving throughthe sclera. It may be further advantageous to add ribs or bumps ofsilicone or similar material to the shoulders to further prevent theflexible circuit cable 12 from moving through the sclera.

Further it is advantageous to provide a suture tab 56 in the flexiblecircuit body near the electronics package to prevent any movement in theelectronics package from being transmitted to the flexible circuitelectrode array 10. Alternatively, a segment of the flexible circuitcable 12 can be reinforced to permit it to be secured directly with asuture.

FIG. 7 shows that it is advantageous to provide a sleeve or coating 50that promotes healing of the sclerotomy. Polymers such as polyimide,which may be used to form the flexible circuit cable 12 and flexiblecircuit electrode array 10, are generally very smooth and do not promotea good bond between the flexible circuit cable 12 and scleral tissue. Asleeve or coating of polyester, collagen, silicone, Gore-Tex or similarmaterial would bond with scleral tissue and promote healing. Inparticular, a porous material will allow scleral tissue to grow into thepores promoting a good bond.

FIG. 8 shows that the flexible circuit electrode array 10 may beinserted through the sclera, behind the retina and placed between theretina and choroid to stimulate the retina subretinally. In this case,it is advantageous to provide a widened portion, or stop, of theflexible circuit cable 12 to limit how far the flexible circuitelectrode array is inserted and to limit the transmission of stressthrough the sclera. The stop may be widening of the flexible circuit 1or it may be added material such as a bumper or sleeve.

A skirt 60 covers the flexible circuit electrode array 10, and extendsbeyond its edges. It is further advantageous to include wings 62adjacent to the attachment point 54 to spread any stress of attachmentover a larger area of the retina. There are several ways of forming andbonding the skirt 60. The skirt 60 may be directly bonded throughsurface activation or indirectly bonded using an adhesive.

Alternatively, a flexible circuit electrode array 10 may be layeredusing different polymers for each layer. Using too soft of a polymer mayallow too much stretch and break the metal traces. Too hard of a polymermay cause damage to delicate neural tissue. Hence a relatively hardpolymer, such a polyimide may be used for the bottom layer and arelatively softer polymer such a silicone may be used for the top layerincluding an integral skirt to protect delicate neural tissue.

The simplest solution is to bond the skirt 60 to the back side (awayfrom the retina) of the flexible circuit electrode array 10 as shown inFIG. 9. While this is the simplest mechanical solution, sharp edges ofthe flexible circuit electrode array 10 may contact the delicate retinatissue. Bonding the skirt to the front side (toward the retina) of theflexible circuit electrode array 10 will protect the retina from sharpedges of the flexible circuit electrode array IO. However, a window 62must be cut in the skirt 60 around the electrodes. Further, it is moredifficult to reliably bond the skirt 60 to the flexible circuitelectrode array 10 with such a small contact area. This method alsocreates a space between the electrodes and the retina which will reduceefficiency and broaden the electrical field distribution of eachelectrode. Broadening the electric field distribution will limit thepossible resolution of the flexible circuit electrode array 10.

FIG. 11 shows another structure where the skirt 60 is bonded to the backside of the flexible circuit electrode array 10, but curves around anysharp edges of the flexible circuit electrode array 10 to protect theretina. This gives a strong bond and protects the flexible circuitelectrode array 10 edges. Because it is bonded to the back side andmolded around the edges, rather than bonded to the front side, of theflexible circuit electrode array 10, the portion extending beyond thefront side of the flexible circuit electrode array 10 can be muchsmaller. This limits any additional spacing between the electrodes andthe retinal tissue.

FIG. 12 shows a flexible circuit electrode array 10 similar to FIG. 11,with the skirt 60, flush with the front side of the flexible circuitelectrode array 10 rather than extending beyond the front side. Whilethis is more difficult to manufacture, it does not lift the electrodesoff the retinal surface as with the array in FIG. 8. It should be notedthat FIGS. 9-12 show skirt 60 material along the back of the flexiblecircuit electrode array 10 that is not necessary other than for bondingpurposes. If there is sufficient bond with the flexible circuitelectrode array 10, it may advantageous to thin or remove portions ofthe skirt 60 material for weight reduction.

Referring to FIG. 13, the flexible circuit electrode array 10 ismanufactured in layers. A base layer of polymer 70 is laid down,commonly by some form of chemical vapor deposition, spinning, meniscuscoating or casting. A layer of metal 72 (preferably platinum) is appliedto the polymer base layer 70 and patterned to create electrodes 74 andtraces for those electrodes. Patterning is commonly done byphotolithographic methods. The electrodes 74 may be built up byelectroplating or similar method to increase the surface area of theelectrode 74 and to allow for some reduction in the electrodes 74 overtime. Similar plating may also be applied to the bond pads 52 (FIG.6-8). A top polymer layer 76 is applied over the metal layer 72 andpatterned to leave openings for the electrodes 74, or openings arecreated later by means such as laser ablation. It is advantageous toallow an overlap of the top polymer layer 76 over the electrodes 74 topromote better adhesion between the layers, and to avoid increasedelectrode reduction along their edges. The overlapping top layerpromotes adhesion by forming a clamp to hold the metal electrode betweenthe two polymer layers. Alternatively, multiple alternating layers ofmetal and polymer may be applied to obtain more metal traces within agiven width.

FIG. 14 shows a perspective view of a flexible electrode with a tackopening 54. The tack opening 54 is in the vicinity of defined, here cshape cut out 541. The cut out 541 decouples force from the tack opening54 to portions of the flexible electrode 12. The cutout 541 allowsindependent deflection of different regions. The cut out 541 as well asthe opening 54 can be manufactured by different process, such as laser,assorted mechanical means, or molding process.

FIG. 15 shows a top view of a modified tack opening 54, which is madethinner and has an increased open angle 542. FIG. 16 shows across-sectional view of a modified tack opening, which is made thinnerand has an increased open angle 542. FIGS. 15 and 16 further explain themodification shown in FIG. 14. By making the material 121 thinnerbetween the tack hole 54 and the cut out 541 it becomes more flexible.

FIG. 17 shows a top view of a modified tack opening, which can be thinheight, rotate better, adjust the angle better and use softer material.FIG. 18 shows a cross-sectional view of a modified tack opening, whichcan be thin height, rotate better, adjust the angle better and usesofter material. FIG. 17 shows an alternative embodiment of theembodiment shown in FIG. 15. The c shaped cut outs may decouple theforces in a different way as discussed before for one c shaped cutout inFIG. 15.

FIG. 19 shows a top view of a modified tack opening, which can adjustthe diameter, and adjust thickness, can use softer materials, can bemanufactured integrally or discretely, flush or protruding. FIG. 20shows a cross-sectional view of a modified tack opening, which canadjust the diameter, and adjust thickness, can use softer materials, canbe manufactured integrally or discretely, flush or protruding. FIG. 19and FIG. 20 show a membrane 543 made of a soft polymer, such as siliconeor mixtures thereof with other soft polymers. The membrane 543 containsthe tack opening 54. This embodiment does not require a gap 541 andpresents a more continues surface.

FIG. 21 shows a cross-sectional view of a modified tack opening 54,which applies to the modifications in FIGS. 14-18, which can be flat(disk) or curved (hemispherical), and can be fabricated with part oradded separately. The FIG. shows in particular a pedestal 544 feature.The potential benefit lies in lifting global electrode region off retinaby a small amount and localizing high pressure on tissue to tack site.

FIG. 22 shows a top view and FIG. 23 shows a cross sectional view of aflexible electrode 12 with a tack opening 54 containing membranematerial 543 and a silicone coating 60. FIG. 22 is similar to FIGS. 19and 20 except that this embodiment is more flat. It could bemanufactured in faster and easier method as the previous variation. Dueto the material properties of the membrane, small static forces aretransferred to the electrode array to maintain contact proximity butlarge, transient forces are not transferred to reduce the likelihood ofarray and/or retinal damage.

Accordingly, what has been shown is an improved method making a neuralelectrode array and improved method of stimulating neural tissue. Whilethe invention has been described by means of specific embodiments andapplications thereof, it is understood that numerous modifications andvariations could be made thereto by those skilled in the art withoutdeparting from the spirit and scope of the invention. It is therefore tobe understood that within the scope of the claims, the invention may bepracticed otherwise than as specifically described herein.

1. A flexible circuit electrode array adapted for neural stimulation, comprising: a polymer base layer: metal traces deposited on said polymer base layer, including electrodes deposited on said traces suitable to stimulate neural tissue; a polymer top layer deposited on said polymer base layer and said metal traces: a second softer polymer over at least a portion of said flexible circuit electrode array: at least one tack opening: wherein said polymer base layer, said metal traces and said polymer top layer are thermoformed in a approximately spherical shape.
 2. The flexible circuit electrode array according claim 1, wherein said polymer base layer, said metal traces and said polymer top layer are curved to approximately the curvature of an eye.
 3. The flexible circuit electrode array according to claim 1, further comprising a narrowed portion in a flexible circuit cable portion of said flexible circuit electrode array.
 4. The flexible circuit electrode array according to claim 1, wherein the tack opening is in the vicinity of at least one cutout.
 5. The flexible circuit electrode array according to claim 1, wherein the polymer base layer surrounding said tack opening is made thinner and has a stress relief C shaped cut out partially surrounding said tack opening.
 6. The flexible circuit electrode array according to claim 1, wherein the tack opening is in the vicinity of at least one c shaped cutout.
 7. The flexible circuit electrode array according to claim 1, wherein the tack opening is in the vicinity of at least two c shaped cutouts.
 8. The flexible circuit electrode array according to claim 1, wherein the tack opening is surrounded by a flat or hemisphere shaped membrane.
 9. The flexible circuit electrode array according to claim 8, wherein the membrane contains a soft polymer.
 10. The flexible circuit electrode array according to claim 9, wherein the soft polymer contains silicone or mixtures thereof with other soft polymers.
 11. The flexible circuit electrode array according to claim 1, wherein the tack opening is surrounded and partially covered by a pedestal.
 12. The flexible circuit electrode array according to claim 11, wherein the pedestal contains a soft polymer.
 13. The flexible circuit electrode array according to claim 12, wherein the soft polymer contains silicone or mixtures thereof with other soft polymers. 